A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

Completed

• Conditions: Melanoma
• Interventions: Other: Non-Interventional

• Registration Number: NCT03732560
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-31
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adults 18 years or older
• First advanced of diagnosis of metastatic/Stage IV) melanoma
• Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
• Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
• Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

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Exclusion Criteria

• Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing treatment with nivolumab	Non-Interventional	-
Patients undergoing treatment with nivolumab and ipilimumab	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) from Advanced Diagnosis	Minimum follow up 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of AE's	Minimum follow up 1 year
Progression Free Survival (PFS) from Advanced Diagnosis	Minimum follow up 1 year
Overall Survival (OS) from 1L Therapy Initiation	Minimum follow up 1 year
Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria	Minimum follow up 1 year
Time to Best Therapy Response	Minimum follow up 1 year
Response Evaluation Criteria in Solid Tumors (RECIST)	Minimum follow up 1 year
Incidence of SAE's	Minimum follow up 1 year
Progression Free Survival (PFS) from Index Date	Minimum follow up 1 year
Objective Response Rate (ORR)	Minimum follow up 1 year
Best Therapy Response	Minimum follow up 1 year	Best response (complete response, CR or partial response, PR) will be measured from the start of index treatment to progression or recurrence. Outcome will be reported as the percent of patients achieving best response from the total population of patients in a study arm.
Time to Loss of Peak Response	Minimum follow up 1 year

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Parsippany, New Jersey, United States